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Authors
Okada, Kazuyoshi https://orcid.org/0009-0008-0725-2688
Hara, Daisuke
Inoue, Tomoko
Tashiro, Manabu
Minakuchi, Jun
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Article History
Received: 21 July 2025
Accepted: 25 November 2025
First Online: 6 December 2025
Declarations
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: This study was approved by the Research Ethics Committee of Kawashima Hospital (1300–1306) on January 7, 2025, and registered in the UMIN Clinical Trials Registry (UMIN000056789 registered 22 January, 2025—prospectively registered, ). All clinical investigations were conducted according to the principles expressed in the Declaration of Helsinki. The need to obtain informed consent was waived by Research Ethics Committee of Kawashima hospital. The research information was disclosed to patients based on Ethical Guidelines for Life Science and Medical Research Involving Human Subjects before enrollment.
: Not applicable.
: K.O., T.I., M.T., and J.M. received funding for specific clinical research (Japan Registry of Clinical Trials registration number jRCTs032220723) from Nipro Co., Ltd., and specific clinical research (Japan Registry of Clinical Trials with the registration number jRCTs062190020) from Asahi Kasei Medical Co., Ltd.. K.O. reports personal fees from Kyowa Kirin Co., Ltd., Bayer Yakuhin, Ltd., Ono Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., AstraZeneca Plc., Torii Pharmaceutical Co., Ltd, Sanwa Kagaku Kenkyusho Co., Kowa Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., and Eli Lilly Japan K.K.. T.I. reports personal fees from Nipro Co., Ltd., Kyowa Kirin Co., Ltd., AstraZeneca Plc., Torii Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Terumo Co. Ltd., JMS Co. Ldt., and Fuso Pharmaceutical Industries, Ltd.. M.T. reports personal fees from Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Toray Medical Co., Ltd., Novartis Pharm Co. Ldt., Otsuka Pharmaceutical Co., Ltd., Nova Biomedical Co., Ldt., and JMS Co. Ldt., J.M. reports personal fees from Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Vantive Japan, AstraZeneca Plc., Torii Pharmaceutical Co., Ltd, Sanwa Kagaku Kenkyusho Co., Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Novartis Pharm Co. Ldt., Otsuka Pharmaceutical Co., Ltd., Chugai Parmaceutical Co., Ltd., Terumo Co. Ltd., and JMS Co. Ldt.. D.H. has no Conflict of Interest.
